Sprix for Postoperative Pain Control Following Gynecologic Surgery

Surgery Clinical Trial

Official title:

Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04444830
• Other study ID #: 19.1351
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2021
• Est. completion date: September 21, 2021

Study information

• Verified date: March 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of opioids that be may prescribed after acute injury, for chronic conditions and following surgery the healthcare industry as a whole continues to search for alternative medications that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition. To that end this study has the following aims:

1. To evaluate the amount of opioids consumed following minimally invasive, female pelvic surgery when patients' postoperative pain is managed via:

1. Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)

2. Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough pain (Sprix protocol)

2. Patient satisfaction with the aforementioned methods

3. Evaluate and compare pain scores via validated questionnaire

Hypothesis:

Primary:

1. Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following minimally invasive female pelvic surgery.

Secondary:

1. Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes maximum experience of pain

2. Patients in the Sprix protocol will have lower numeric pain score and on POD#4

3. Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores on POD#1

4. Patients in the Sprix protocol will have higher QoR-40 scores on POD#4

5. Patients will not have any significant difference in overall surgical satisfaction on POD#1 and POD#4 using a numerical satisfaction score

6. Patients in the Sprix protocol will be more likely to consume no narcotics at all once discharged to home

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years of age

2. Weight = 110lbs

3. English Speaking and Reading

4. All consecutive, consenting female patients undergoing Pelvic Organ Prolapse (POP) surgery - vaginal prolapse surgery, laparoscopic vaginal prolapse surgery or robotic assisted vaginal prolapse surgery - with or without Bilateral or Unilateral Salpingoopherectomy, with or without concomitant hysterectomy, with or without urinary anti-incontinence surgery

Exclusion Criteria:

1. Patients taking opioids chronically at the time of surgery

2. History of Coronary Artery Bypass Graft (CABG)

3. History of peptic ulcer disease or bleeding in the stomach or intestines

4. History of asthma attack, hives, or other allergic reaction with aspirin or any other Non-Steroidal Anti-inflammatory Drug (NSAID)

5. Uncontrolled hypertension at the time of consent and/or surgery

6. History of renal impairment as defined by blood creatinine of 1.1 or greater at any time

Related Conditions & MeSH terms

• Enuresis
• Narcotic Use
• Pain, Postoperative
• Pelvic Organ Prolapse
• Post Operative Pain Control
• Prolapse
• Surgery
• Urinary Incontinence
• Urinary Incontinence , Stress
• Urinary Incontinence, Stress

Intervention

Drug:
• Sprix
Intranasal Ketorolac - used as directed for an appropriate, previously established indication

Locations

Country	Name	City	State
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (4)

Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736. Erratum in: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text. — View Citation

Pergolizzi JV Jr, Taylor R Jr, Raffa RB. Intranasal ketorolac as part of a multimodal approach to postoperative pain. Pain Pract. 2015 Apr;15(4):378-88. doi: 10.1111/papr.12239. Epub 2014 Aug 28. Review. — View Citation

Pollack CV Jr, Diercks DB, Thomas SH, Shapiro NI, Fanikos J, Mace SE, Rafique Z, Todd KH. Patient-reported Outcomes from A National, Prospective, Observational Study of Emergency Department Acute Pain Management With an Intranasal Nonsteroidal Anti-inflammatory Drug, Opioids, or Both. Acad Emerg Med. 2016 Mar;23(3):331-41. doi: 10.1111/acem.12902. — View Citation

Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564. Erratum in: Curr Med Res Opin. 2012 Jun;28(6):1052. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine mEqs	The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents	As measured from the day of surgery to 4 days post operative
Secondary	Patient Satisfaction	Evaluate patient satisfaction using the validated QoR 40 (Quality of Recovery) Scale - wherein a minimum score of 40 indicates that a patient perceives there recovery to be very poor and a maximum score of 200 indicates that the patient perceives that the quality of their recovery is excellent	Day of surgery to 4 days postoperative
Secondary	Patient's perception of current pain	The patient's pain will be subjectively scaled on a 0 (indicating no pain) to 10 (indicating maximum/severe pain) scale. The patient will be asked to scale their pain preoperatively, on postoperative day #1 and on Postoperative day #4	Day of surgery to 4 days postoperatively